A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.
At this week’s iPhone 5 announcement, Apple confirmed something of an open secret among those companies that make health peripherals for iOS devices: The longstanding 30-pin connector dock has been swapped out for a new slimmer, redesigned connector dock that Apple calls Lightning. MobiHealthNews